> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Accepts 2 Keytruda sBLAs for Review
- URL: https://www.fdaweb.com/fda-accepts-2-keytruda-sblas-for-review/
- Published: 2021-08-10T12:00:00.000Z
- Updated: 2026-09-14T17:09:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149902

FDA has accepted for review two Merck supplemental BLAs for its anti-PD-1 therapy Keytruda **(pembrolizumab). One submission was** accepted for priority review for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy (surgical removal of a kidney), or following nephrectomy and resection of metastatic lesions. The other submission was accepted for standard review for treating patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and are not candidates for curative surgery or radiation.  

The RCC submission is based on data from the pivotal Phase 3 KEYNOTE-564 trial, in which Keytruda demonstrated a statistically significant and clinically meaningful improvement in disease-free survival compared to placebo, according to the company. The user fee review action target data us 12/10.  

The endometrial carcinoma submission is based on overall response data from cohorts D and K of the KEYNOTE-158 trial, which has a primary endpoint of overall response rate, Merck says. Secondary endpoints are progression-free survival, overall survival, duration of response, and safety. FDA set a user fee review action date if 3/28/2022.